Cleared Traditional

K200995 - Insignia Anterior Cervical Plate System

K200995 is the FDA 510(k) clearance for Insignia Anterior Cervical Plate System by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K200995 · Alphatec Spine, Inc. · Orthopedic device
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May 2020
Decision
35d
Days
Class 2
Risk

K200995 is an FDA 510(k) clearance for the Insignia™ Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsnad, US). The FDA issued a Cleared decision on May 21, 2020 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alphatec Spine, Inc. devices

Submission Details

510(k) Number K200995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2020
Decision Date May 21, 2020
Days to Decision 35 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 435
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K200995.
CarboClear® Cervical Plate System
K200883 · CarboFix Orthopedics , Ltd. · Jun 2020
Meridian Anterior Plate System, Regatta Lateral Plate System
K200885 · SeaSpine Orthopedics Corporation · May 2020
NuVasive Thoracolumbar Plates
K200956 · Nu Vasive, Incorporated · May 2020
NuVasive® ACP System
K201078 · Nu Vasive, Incorporated · May 2020
Cure™ Lumbar Plate System
K201136 · Meditech Spine, LLC · May 2020
Balteum™ Lumbar Plate System
K200846 · Huvexel Co. , Ltd. · May 2020